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临床试验/NCT06692400
NCT06692400招募中不适用

The Impact of Endotracheal Suctioning on Pain, Hypoxia, and Oxidative Stress Biomarkers in Intubated Adult ICU Patients: A Controlled Trial

Loma Linda University1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2025年1月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
110
试验地点
1
主要终点
Impact of ETT suctioning on subject pain level

研究概览

简要总结

The goal of this experimental study is to understand if endotracheal tube (ETT) suctioning increases pain and causes stress on the body in intubated adult ICU patients. These patients are already on ventilators, which means they need suctioning to keep their airways clear, but this procedure may be uncomfortable and cause stress.

The main questions this study aims to answer are:

Does ETT suctioning raise pain levels as measured by the Critical-Care Pain Observation Tool (CPOT)? Does ETT suctioning increase certain chemicals in the blood (hypoxanthine, xanthine, and uric acid) that show stress and lack of oxygen in the body? Researchers will compare patients who have ETT suctioning (intervention group) with those who do not have suctioning during the study period (control group) to see if there are differences in pain and blood markers of stress.

Participants will:

Have pain measured before and after suctioning using the CPOT. Have blood samples taken from an existing line at three time points: 5 minutes before, 5 minutes after, and 30 minutes after suctioning.

Provide demographic information (like age, gender, and diagnosis) from medical records.

This research will help improve how pain is managed for ICU patients who cannot speak for themselves, potentially leading to better pain relief methods in the future.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Investigator)

盲法说明

The lab technician who results the labs will be blinded.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults (aged 18 years and older)
  • •Current diagnosis of flu, pneumonia, COVID, or sepsis
  • •Intubated and receiving mechanical ventilation.
  • •Have arterial lines placed
  • •Require endotracheal suctioning as part of their care

排除标准

  • •Patients receiving neuromuscular blocking agents
  • •Contraindications for blood draws (hemoglobin levels below 8.0 g/dL; Jehovah's Witness)

研究组 & 干预措施

Participants who undergo endotracheal tube (ETT) suctioning.

Experimental

Participants will receive ETT suctioning as part of routine care.

干预措施: endotracheal tube suctioning (Procedure)

Participants who do not undergo ETT suctioning during the observation period.

No Intervention

Participants will not receive ETT suctioning during the observation periood.

结局指标

主要结局

Impact of ETT suctioning on subject pain level

时间窗: Change between baseline CPOT score and 30-minutes post suctioning CPOT score.

The Critical-Care Pain Observation Tool (CPOT) is a composite measurement used to assess pain in non-verbal ICU patients by evaluating four behavioral indicators: facial expression, body movements, muscle tension, and ventilator compliance (for intubated patients) or vocalization (for non-intubated patients). Each indicator is scored from 0 (no pain behavior) to 2 (intense pain behavior), resulting in a total score from 0 to 8. Higher scores indicate higher pain levels, guiding clinicians in pain management. For example, a score of 0 indicates no pain, while a score of 2 in any category suggests more severe pain, prompting possible adjustments in analgesic care.

Impact of ETT suctioning on subject serum markers of hypoxia and oxidative stress (Hypoxanthine).

时间窗: Change between baseline serum marker blood draw and 30-minutes post suctioning serum marker blood draw

Serum markers will be obtained via arterial line blood draw 5 minutes pre-ETT suctioning and again post-ETT suctioning. Normal blood concentrations of hypoxanthine in healthy adult individuals are less than 5 µmol. Levels greater than 5 µmol indicate hypoxia and oxidative stress.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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